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Takeda abandons phase III diabetes drug

Published on 05/04/05 at 11:37am

Takeda has been forced to abandon one of its lead pipeline products after a small number of patients in clinical trials developed liver problems.

The drug, TAK-559, a non-thiazolidinedione insulin sensitiser, was in phase III and was an important follow-up to Actos, currently one of the company's leading brands.

The problems, centering around abnormalities in liver enzyme tests were first discovered in December, leading to the suspension of trials, but the company has now confirmed it will discontinue the drug's development, citing an insufficient benefit/risk profile in relation to existing treatments.

The Japanese company is facing the patent expiry on one of its biggest drugs Prevacid, in 2009 and has few remaining compounds in its pipeline.

The company has declared a new drive to bolster its development programme by in-licensing promising drugs, but has so far failed to identify any major candidates.

New diabetes drugs have proven to be one of the most treacherous drug development areas, with a number of high profile industry failures.

In October last year AstraZeneca announced its product Galida would be delayed after clinical trial administrators demanded more time to investigate safety concerns - the drug is now expected to be filed in 2007.

Merck dropped its late-stage dipeptidyl peptidase IV inhibitor in late 2003 and Exubera, the new inhaled insulin formulation from Sanofi-Aventis and Pfizer has been severely delayed, but could soon be approved in Europe.

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